知识共享:药物创新中的社会困境。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2016-01-01
Daria Kim
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引用次数: 0

摘要

这篇文章解决了限制获取行业赞助的临床试验数据的问题。特别是,它分析了相互竞争的主张的交集,即强制性披露药物试验数据阻碍了药物赞助商的创新激励,而获取有助于新药开发。这些主张的特点是公共利益和共同资源的困境。分析发现,原始研究数据的保密保护起到了模糊的作用。虽然保密本身并不能解决制药创新中的公益问题(在存在保护原始药物免受仿制药竞争的监管文书的情况下),但鉴于数据是科学知识的来源,保密可能会加剧公共资源问题。有人认为,研究型行业声称临床数据披露阻碍了创新激励的说法是错误的,不应该用来对抗支持获取的政策。虽然人们对药物研发投资的适当性问题给予了很多关注,但本分析强调了私人提供临床试验所造成的另一个后果,即药物赞助商对事实保密和拥有数据。相关的社会成本在内部化知识外部性方面是合格的。由于在竞争环境中,公司不太可能改变不共享原始数据的战略,因此部门层面的经济低效需要监管干预。为了协调相互竞争的政策目标,建议在设计获取规则时,应使第三方对原始数据的使用不会干扰对非专利竞争的保护。同时,当“合作选择”(即所有人共享数据)成为“优势策略”时,可以实现长期集体利益最大化。只有在不受初始试验发起人授权的情况下,以及在集体基础上汇总、精炼和管理原始数据时,才能实现这一点。
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Knowledge Sharing as a Social Dilemma in Pharmaceutical Innovation.

This article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyzes the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes drug sponsors’ innovation incentives and that access facilitates new drug development. These claims are characterized in terms of public-good and common-resource dilemmas. The analysis finds confidentiality protection of primary research data plays an ambiguous role. While secrecy, as such, does not solve the public-good problem in pharmaceutical innovation (in the presence of regulatory instruments that protect the originator drug against generic competition), it is likely to exacerbate the common-resource problem, in view of data as a source of scientific knowledge. It is argued that the claim by the research-based industry that disclosure of clinical data impedes innovation incentives is misplaced and should not be leveraged against pro-access policies. While much attention has been paid to the problem of appropriability of drug R&D investment, this analysis highlights another consequence resulting from the private provision of clinical trials, i.e., factual confidentiality and possession of data by drug sponsors. The associated social costs are qualified in terms of internalized knowledge externalities. Since, in a competitive environment, companies are unlikely to change the strategy of non-sharing of primary data, the resulting economic inefficiencies at the sector level call for regulatory intervention. To reconcile the competing policy objectives, it is proposed that the rules of access should be designed in such a way that third-party use of primary data does not interfere with protection against generic competition. At the same time, the long-term collective benefit can be maximized when the “cooperative choice” (i.e., when everyone shares data) becomes the “dominant strategy.” This can be achieved only when access is not subject to the authorization of the initial trial sponsors, and when primary data is aggregated, refined, and managed on the collective basis.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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